Single IRB Review and Reliance Agreements

 

What is a reliance agreement?

A reliance agreement is a formal agreement that allows an institution engaged in research to delegate or cede IRB oversight of a research study or group of studies to an independent IRB or IRB at another institution. 

The following arrangements occur under such agreements:

  • OUHSC IRB may serve as the reviewing IRB or
  • OUHSC may defer IRB oversight to an external IRB to serve as the reviewing IRB


Reliance agreements may also be referred to as IRB Authorization Agreements (IAAs). The arrangement of one IRB relying on another IRB may also be referred to as deferring to a central or single IRB (sIRB), deferring IRB oversight, or relying on an external IRB.

 

 

Why might I need a reliance agreement?

  The National Institutes of Health has required that a single IRB review NIH-funded multi-site studies that were approved on or after January 25, 2018. Additionally, under the Revised Common Rule, most U.S. government funded cooperative studies that meet the criteria for non-exempt human subjects research and involve more than one site will also require single IRB review. This requirement goes into effect on January 20, 2020.

 

 

How do I initiate a reliance agreement?

At OUHSC, researchers may be permitted to enter a reliance agreement upon request. These determinations are made on a case-by-case basis by the OUHSC IRB, HRPP, and appropriate University officials.

The process for requesting to enter a reliance agreement varies depending on whether OUHSC IRB will serve as the reviewing IRB for a non-OU site or whether OUHSC will defer review to an outside IRB. 

See below for more information.

iRIS.ouhsc.edu Request to Use an External IRB form


OUHSC has joined the SMART IRB Network

SMART IRB is an online reliance system designed to ease common challenges associated with initiating multisite research and provide a roadmap for institutions to implement the singe IRB review. Its integrated, comprehensive platform allows flexibility in the size and scope of collaboration and enables IRB reliance for multisite studies across the nation, regardless of funding status. 

OUHSC investigators may utilize this online reliance agreement system to track, coordinate, and execute agreements if the external IRB is also a SMART IRB member. However, OUHSC still requires University concurrence before the OUHSC PI and external IRB can proceed with the reliance agreement in SMART IRB.

 

 

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